Ironwood and Allergan settle with Mylan over patent litigation

Ironwood Pharmaceutical (Nasdaq: IRWD) and Allergan (NYSE: AGN) have reached an agreement with Mylan Pharmaceuticals (Nasdaq: MYL) resolving patent litigations brought in response to Mylan’s Abbreviated New Drug Applications (ANDAs) approval to market generic versions of Linzess (linaclotide) prior to the expiration of the companies’ applicable patents.

The settlement with Mylan is the third patent infringement settlement the companies have reached with respect to Linzess, a drug used to treat irritable bowel syndrome with constipation and chronic constipation.

Under the terms of the settlement, Ironwood and Allergan will grant Mylan a license to market its generic version of Linzess 145mcg and 290mcg in the USA beginning February 5, 2030, and its generic version of Linzess 72mcg in the USA from August 5, 2030 (both subject to US Food and Drug Administration approval), unless certain limited circumstances, customary for settlement agreements of this nature, occur. As a result of the settlement, all ongoing Hatch-Waxman litigations between the companies and Mylan regarding Linzess patents pending in the US District Court for the Northern District of West Virginia will be dismissed. Additional details regarding the settlement were not disclosed.